Furlong Eileen, Darley Andrew, Fox Patricia, Buick Alison, Kotronoulas Grigorios, Miller Morven, Flowerday Adrian, Miaskowski Christine, Patiraki Elisabeth, Katsaragakis Stylianos, Ream Emma, Armes Jo, Gaiger Alexander, Berg Geir, McCrone Paul, Donnan Peter, McCann Lisa, Maguire Roma
School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland.
School of Psychological Sciences and Health, University of Strathclyde, Glasgow, United Kingdom.
JMIR Cancer. 2019 Mar 14;5(1):e10813. doi: 10.2196/10813.
There has been an international shift in health care, which has seen an increasing focus and development of technological and personalized at-home interventions that aim to improve health outcomes and patient-clinician communication. However, there is a notable lack of empirical evidence describing the preparatory steps of adapting and implementing technology of this kind across multiple countries and clinical settings.
This study aimed to describe the steps undertaken in the preparation of a multinational, multicenter randomized controlled trial (RCT) to test a mobile phone-based remote symptom monitoring system, that is, Advanced Symptom Management System (ASyMS), designed to enhance management of chemotherapy toxicities among people with cancer receiving adjuvant chemotherapy versus standard cancer center care.
There were 13 cancer centers across 5 European countries (Austria, Greece, Ireland, Norway, and the United Kingdom). Multiple steps were undertaken, including a scoping review of empirical literature and clinical guidelines, translation and linguistic validation of study materials, development of standardized international care procedures, and the integration and evaluation of the technology within each cancer center.
The ASyMS was successfully implemented and deployed in clinical practices across 5 European countries. The rigorous and simultaneous steps undertaken by the research team highlighted the strengths of the system in clinical practice, as well as the clinical and technical changes required to meet the diverse needs of its intended users within each country, before the commencement of the RCT.
Adapting and implementing this multinational, multicenter system required close attention to diverse considerations and unique challenges primarily related to communication and clinical and technical issues. Success was dependent on collaborative and transparent communication among academics, the technology industry, translation partners, patients, and clinicians as well as a simultaneous and rigorous methodological approach within the 5 relevant countries.
医疗保健领域出现了国际转变，越来越关注并发展旨在改善健康结果以及患者与临床医生沟通的技术和个性化居家干预措施。然而，明显缺乏实证证据来描述在多个国家和临床环境中采用和实施这类技术的准备步骤。
本研究旨在描述为开展一项跨国、多中心随机对照试验（RCT）所采取的步骤，该试验旨在测试一种基于手机的远程症状监测系统，即高级症状管理系统（ASyMS），旨在增强接受辅助化疗的癌症患者化疗毒性管理，与标准癌症中心护理进行对比。
来自5个欧洲国家（奥地利、希腊、爱尔兰、挪威和英国）的13个癌症中心参与研究。采取了多个步骤，包括对实证文献和临床指南进行范围综述、对研究材料进行翻译和语言验证、制定标准化国际护理程序，以及在每个癌症中心对技术进行整合和评估。
ASyMS在5个欧洲国家的临床实践中成功实施和部署。研究团队严格且同步采取的步骤凸显了该系统在临床实践中的优势，以及在RCT开始前满足每个国家目标用户多样化需求所需的临床和技术变革。
采用和实施这个跨国、多中心系统需要密切关注主要与沟通以及临床和技术问题相关的各种考量和独特挑战。成功取决于学术界、技术行业、翻译合作伙伴、患者和临床医生之间的协作与透明沟通，以及5个相关国家同步且严格的方法学途径。
